Research Regulatory Coordinator

American Oncology Network•Urbana, IL

1d•$25 - $44•Remote

About The Position

The Research Regulatory Coordinator is responsible for collaborating with Principal Investigators (PIs) and internal/external clinical research team members within the scope of clinical trial regulatory submission and compliance. This role involves assisting in the preparation of regulatory submissions and maintaining regulatory files. The coordinator will prepare regulatory documents for submission to the Institutional Review Board (IRB) or other IRBs, internal committees, and the FDA, including initial submissions, continuing reports, amendments, addendums to research protocols and consent documents, and Adverse Event reporting. Collaboration with study team members is essential for these duties. The position requires maintaining master regulatory files in accordance with institutional, state, and federal regulations, demonstrating a working knowledge of all facets of the role, relevant regulations, and organizational/departmental policies and procedures. Other duties and projects as assigned will be performed in accordance with regulatory requirements and organizational policies and procedures.

Requirements

High school education required
Valid state Driver’s License for travel to satellite offices and offsite meetings.
Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required.
Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills.
Must be detailed oriented with the ability to exercise independent judgment.
Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness.
Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.
Good command of the English language.
Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.
Strong customer focus.
Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.
Effectively manages own time, conflicting priorities, self, stress, and professional development.
Self-motivated and self-starter with ability work independently with limited supervision.
Ability to work remotely effectively as required.
Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.
Proficiency in MS Office Word, Excel, Power Point, and Outlook expected.

Nice To Haves

Bachelors’ degree in Biological Science, Social Sciences, English, or other related field preferred
Prior clinical research experience is preferred but not required.
Second language is an asset but not required.

Responsibilities

Creates and maintains central regulatory files in accordance with site SOP.
Adheres to and maintains working knowledge of practice policies, Federal regulations, ICH, and GCP guidelines.
Assures patient records are kept confidential and secure in compliance with HIPAA.
Maintains investigative site study files and regulatory binders.
Responsible for the preparation of archiving closed studies for long-term storage.
Collects and maintains study-specific documentation for main and satellite locations in the appropriate Regulatory Binder and electronic document system.
Creates and maintains Research Delegation of Authority logs and role-specific profiles, ensuring revised profiles are provided to investigators and research staff as roles and responsibilities necessitate.
Creates and maintains study-specific FDA Form 1572, ensuring the form is reconciled and updated as changes necessitate.
Collects and maintains Financial Disclosure Forms as completed by investigators, escalating reported disclosures to leadership if reported.
Maintains historical credentials for all current and previous Investigators and research staff, laboratory licenses, CLIA/COLA in collaboration with various departments.
Produces documentation as needed for Sponsor/CRO review.
Maintains credible documentation by using the ALCOAC method (Attributable, Legible, Contemporaneous, Original, Accurate, Complete).
Supports GCP and protocol-specific training for staff and investigators by uploading and archiving protocol-specific training modules for all studies.
Distributes training module assignments and maintains documentation of GCP training for all research staff and investigators according to site SOP.
Ensures completion, submission, and subsequent distribution of IRB-approved documents in accordance with site SOP.
Processes regulatory documents: initial submission, ongoing required documents for each study, continuing review, and study closure procedures in accordance with GCP, ICH/FDA requirements.
Processes IND safety reports.
Prepares and ensures timely reporting and submissions to the IRB in accordance with site SOP and federal regulations, including initial IRB submission and approval at study activation.
Obtains documentation of IRB approvals, including amendments and revisions to study-related documents, such as revised informed consents and protocols, and maintains them in the Regulatory Binder.
Completes IRB Continuing Review reports required by the IRB and submits them to the applicable IRB.
Files all correspondence regarding continuing review report submission in the Regulatory Binder.
Ensures the process is followed for reporting any Serious Adverse Event (SAE) to the IRB that meets IRB reporting guidelines, as determined by the PI.
Notifies Research Coordinators and applicable investigators via email when a new/amended Protocol or ICF has been IRB approved.
Ensures research coordinators are provided IRB instructions for re-consenting subjects in a timely manner.
Reviews signed ICFs for completeness and notifies the Research Coordinator of any discrepancies.
Maintains internal log of consent versions.
Maintains a master subject/enrollment list electronically for each study until the study is terminated and records are ready to archive.
Supports on-site and remote monitoring activities by scheduling and preparing for interim monitoring visits (IMV) and ensuring the Regulatory Binder is complete prior to IMV.
Works collaboratively with the research coordinator to ensure any noted discrepancies during monitoring visits are corrected.
Requests that the monitor summarize any findings, issues, or concerns during the visit in a follow-up letter and notes the status of resolution.
Meets with the Sponsor representative as needed during visits to ensure issues are resolved appropriately and in a timely manner.
Maintains the Site Visit Log and ensures monitors complete the log prior to departure.
Reviews monitor reports/letters following the IMV and forwards them to appropriate staff for review.
Ensures all identified issues are addressed prior to the next monitoring visit.
Maintains a copy of the letters in the Regulatory Binder.
Completes daily communication with the Sponsor/CRO and responds in a timely manner.
Works with the monitor to schedule, prepare, and conduct the Study Termination Visit.
Ensures all study documents are filed and any discrepancies are addressed prior to the scheduled Study Termination Visit.
Sends required documents to Sarah Cannon and ensures all electronic documents and reporting systems are final signed.
After study closure and all queries have been resolved, ensures files are packaged and archived.
Prepares for internal and external audits by retrieving all documents and ensuring all study-related documents are complete prior to the audit.
Performs other duties and projects as assigned.